BPH-6: Comparison of the UroLift System to TURP for Benign Prostatic Hyperplasia

Not Applicable

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Device: UroLift System; Procedure: Transurethral Resection of the Prostate

• Registration Number: NCT01533038
• Lead Sponsor: NeoTract, Inc.

Brief Summary

The purpose of this study is to compare the UroLift System Treatment to Transurethral Resection of the Prostate (TURP) in improving a patient's overall quality of life, while evaluating healthcare expenditures associated with each therapy.

Detailed Description

The study is a prospective, consecutive, multi-center, 1:1 randomized study (UroLift System:TURP). The study is intended to be conducted at up to 20 different centers in Europe and Canada to enroll up to 100 subjects.

Subject follow-up visits are at 2 weeks, 1, 3, 6, 12 and 24 months for all subjects.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-10
• Study First Submitted QC: 2012-02-14
• Study First Posted: 2012-02-15
• Primary Completion: 2015-10
• Results First Submitted: 2015-10-22
• Results First Submitted QC: 2015-10-22
• Results First Posted: 2015-11-26
• Study Completion: 2016-01
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-20
• Last Update Posted: 2017-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

• Men >50 years old with moderate-severe BPH

Read More

Exclusion Criteria

• Size, width of prostate
• Other medical condition or co-morbidity contraindicative for TURP or UroLift

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UroLift System	UroLift System	UroLift System procedure
Transurethral Resection of the Prostate	Transurethral Resection of the Prostate	Transurethral Resection of the Prostate surgery

Primary Outcome Measures

Name	Time	Method
Responder Analysis: A Subject is a Responder at the 12 Month Follow-up Time Point if All 6 Thresholds of the BPH-6 Endpoint Are Met	Month 12	1. LUTS: ≥ 30% reduction in IPSS compared to baseline; 2. Recovery Experience: Return to pre-operative activity levels by 1 month; 3. Erectile function: Less than 6-point reduction in SHIM compared to baseline.; 4. Ejaculatory function: Response on MSHQ-EjD that indicates emission of semen. This excludes the response "Could not ejaculate"; 5. Continence: ISI score of 4 points or less at all follow-up time points; 6. Safety: No procedure-related adverse event greater than Grade I on the Clavien-Dindo classification system modified for TURP at any time during procedure or follow up.

Trial Locations

Locations (9)

University Hospital Tuebingen; 🇩🇪 Tuebingen, Germany

Ludwigs-Maximilians Universität / Klinikum Großhadern; 🇩🇪 Munich, Germany

Musgrove Park Hospital; 🇬🇧 Taunton, United Kingdom

Herlev Hospital; 🇩🇰 Herlev, Denmark

PAN Klinik; 🇩🇪 Cologne, Germany

University Hospital Freiburg; 🇩🇪 Freiburg, Germany

Frimley Park Hospital; 🇬🇧 Frimley, United Kingdom

City Hospitals Sunderland NHS Foundation Trust; 🇬🇧 Sunderland, United Kingdom

The Royal Hallamshire Hospital; 🇬🇧 Sheffield, United Kingdom